Gemcitabine 200mg & 1g powder for solution for infusion

In this leaflet:

• 1. What Gemcitabine powder is and what it is used for
• 2. Before you use
• 3. How to use
• 4. Possible side effects
• 5. How to store
• 6. Further information

You should not be given Gemcitabine powder

• if you are allergic (hypersensitive) to gemcitabine or any of the other ingredients of Gemcitabine powder
• if you are breast-feeding

Take special care with Gemcitabine powder

Before the first infusion you will have samples of your blood taken to evaluate if you have sufficient kidney and liver function. Before each infusion you will have samples of your blood taken to evaluate if you have enough blood cells to receive Gemcitabine powder. Your doctor may decide to change the dose or delay treating you depending on your general condition and if your blood cell counts are too low. Periodically you will have samples of your blood taken to evaluate your kidney and liver function.

Please tell your doctor if:

• you have, or have previously had liver disease, heart disease or vascular disease
• you have recently had, or are going to have radiotherapy
• you have been vaccinated recently
• you develop breathing difficulties or feel very weak and are very pale (may be a sign of kidney failure).

Men are advised not to father a child during and up to 6 months following treatment with Gemcitabine powder. If you would like to father a child during the treatment or in the 6 months following treatment, seek advice from your doctor or pharmacist. You may want to seek counselling on sperm storage before starting your therapy.

Taking other medicines

Please tell your doctor or hospital pharmacist if you are taking or have recently taken any other medicines, including vaccinations and medicines obtained without a prescription.

Pregnancy and breast-feeding

If you are pregnant, or thinking about becoming pregnant, tell your doctor. The use of Gemcitabine powder should be avoided during pregnancy. Your doctor will discuss with you the potential risk of taking Gemcitabine powder during pregnancy.

If you are breast-feeding, tell your doctor.

You must discontinue breast-feeding during Gemcitabine powder treatment.

Driving and using machines

Gemcitabine powder may make you feel sleepy, particularly if you have consumed any alcohol. Do not drive a car or use machinery until you are sure that Gemcitabine powder treatment has not made you feel sleepy.

Important information about some of the ingredients of Gemcitabine powder

Gemcitabine contains 3.56mg (< 1 mmol) of sodium in each 200mg vial and 17.81mg (< 1 mmol) sodium in each 1000mg vial. To be taken into consideration by patients on a controlled sodium diet.

Frequencies of the observed side effects are defined as:

• very common: affects more than 1 user in 10
• common: affects 1 to 10 users in 100
• uncommon: affects 1 to 10 users in 1,000
• rare: affects 1 to 10 users in 10,000
• very rare: affects less than 1 user in 10,000
• not known: frequency can’t be estimated from the available data

You must contact your doctor immediately if you notice any of the following:

• Fever or infection (common): if you have a temperature of 38ºC or greater, sweating or other signs of infection (since you might have less white blood cells than normal which is very common).
• Irregular heart rate (arrhythmia) (frequency not known).
• Pain, redness, swelling or sores in your mouth (common).
• Allergic reactions: if you develop skin rash (very common) / itching (common), or fever (very common).
• Tiredness, feeling faint, becoming easily breathless or if you look pale (since you might have less haemoglobin than normal which is very common).
• Bleeding from the gums, nose or mouth or any bleeding that would not stop, reddish or pinkish urine, unexpected bruising (since you might have less platelets than normal which is very common).
• Difficulty breathing (it is very common to have mild breathing difficulty soon after the gemcitabine infusion which soon passes, however uncommonly or rarely there can be more severe lung problems).

Side effects with Gemcitabine powder may include:

Very common side effects

Low haemoglobin level (anaemia)

Low white blood cells

Low platelet count

Difficulty breathing

Vomiting

Nausea

Skin rash- allergic skin rash, frequently itchy

Hair loss

Liver problems: found through abnormal blood test results

Blood in urine

Abnormal urine tests: protein in urine

Flu like symptoms including fever

Oedema (swelling of ankles, fingers, feet, face)

Common side effects

Fever accompanied by low white blood cell count (febrile neutropaenia)

Anorexia (poor appetite)

Headache

Insomnia

Sleepiness

Cough

Runny nose

Constipation

Diarrhoea

Pain, redness, swelling or sores in the mouth

Itching

Sweating

Muscle pain

Back pain

Fever

Weakness

Chills

Uncommon side effects

Interstitial pneumonitis (scarring of the air sacs of the lung)

Spasm of the airways (wheeze)

Abnormal chest X ray/scan (scarring of the lungs)

Rare side effects

Heart attack (myocardial infarction)

Low blood pressure

Skin scaling, ulceration or blister formation

Injection site reactions

Very rare side effects

Increased platelet count

Anaphylactic reaction (severe hypersensitivity/ allergic reaction)

Sloughing of skin and severe skin blistering

Side effects with frequency not known

Irregular heart beat (arrhythmia)

Adult Respiratory Distress Syndrome (severe lung inflammation causing respiratory failure)

Radiation recall-(a skin rash like severe sunburn) which can occur on skin that has previously been exposed to radiotherapy.

Fluid in the lungs

Radiation toxicity- scarring of the air sacs of the lung associated with radiation therapy

Ischemic colitis (inflammation of the lining of the large bowel, caused by reduced blood supply)

Heart failure

Kidney failure

Gangrene of fingers or toes

Serious liver damage, including liver failure

Stroke

What Gemcitabine powder contains

• The active substance is gemcitabine (as hydrochloride). One vial Gemcitabine powder contains 200mg or 1g gemcitabine.
  After reconstitution one ml of Gemcitabine powder contains 38mg gemcitabine.
• The other ingredients are mannitol E421, sodium acetate trihydrate and sodium hydroxide 1 N (for pH adjustment)

What Gemcitabine powder looks like and contents of the pack

Gemcitabine powder is a white to off-white compact aggregate powder. After reconstitution in 0.9% sodium chloride solution, the solution is clear to pale opalescent and colourless to pale yellow.

Gemcitabine powder is in colourless glass vials with bromobutylic rubber stopper. Each vial will be packed with or without a protective plastic overwrap.

Pack sizes

One vial containing 200mg Gemcitabine.

One vial containing 1g Gemcitabine.

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Manufacturer